80 FR 65687 - Syngenta Seeds Inc.; Availability of Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Glyphosate and Glufosinate-Ammonium Resistance

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 207 (October 27, 2015)

We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of corn events Bayer/Genective S.A.VCO-01981-5 (hereinafter Genective VCO-01981-5 corn) and Pioneer's DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event MZHG0JG in response to a request from Syngenta Seeds Inc. MZHG0JG corn has been genetically engineered for resistance to the herbicide glyphosate using the same mechanism of action as Genective VCO-01981-5 and also to be resistant to the herbicide glufosinate using the same mechanism of action as Pioneer 4114. We are making available for public comment our preliminary finding of no significant impact for the proposed determination of nonregulated status.

[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65687-65689]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27296]


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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / 
Notices

[[Page 65687]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0080]


Syngenta Seeds Inc.; Availability of Preliminary Finding of No 
Significant Impact and Preliminary Decision for an Extension of a 
Determination of Nonregulated Status of Corn Genetically Engineered for 
Glyphosate and Glufosinate-Ammonium Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has reached a preliminary decision to extend our 
determination of nonregulated status of corn events Bayer/Genective 
S.A.VCO-01981-5 (hereinafter Genective VCO-01981-5 corn) and Pioneer's 
DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event 
MZHG0JG in response to a request from Syngenta Seeds Inc. MZHG0JG corn 
has been genetically engineered for resistance to the herbicide 
glyphosate using the same mechanism of action as Genective VCO-01981-5 
and also to be resistant to the herbicide glufosinate using the same 
mechanism of action as Pioneer 4114. We are making available for public 
comment our preliminary finding of no significant impact for the 
proposed determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
November 27, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0080.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0080, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    The Syngenta Seeds Inc. extension request, our preliminary finding 
of no significant impact, our preliminary determination, and any 
comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0080 or in our reading 
room, which is located in Room 1141 of the USDA South Building, 14th 
Street and Independence Avenue SW., Washington, DC. Normal reading room 
hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. 
To be sure someone is there to help you, please call (202) 799-7039 
before coming.
    Supporting documents and any comments we received regarding our 
determination of nonregulated status of the antecedent organisms, 
Genective VCO-01981-5 corn and Pioneer 4114 corn, can be found at 
http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0046 and http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0026. Supporting 
documents may also be found on the APHIS Web site for MZHG0JG corn (the 
organism under evaluation) under APHIS Petition Number 15-124-01p, and 
the antecedent organisms Genective VCO-01981-5 corn and Pioneer 4114 
corn under APHIS Petition Numbers 11-342-01p and 11-244-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 20737-1236; 
(301) 851-3954, email: [email protected]. To obtain copies 
of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, 
email: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (PPA) (7 U.S.C. 7701 et seq.), 
the regulations in 7 CFR part 340, ``Introduction of Organisms and 
Products Altered or Produced Through Genetic Engineering Which Are 
Plant Pests or Which There Is Reason to Believe Are Plant Pests,'' 
regulate, among other things, the introduction (importation, interstate 
movement, or release into the environment) of organisms and products 
altered or produced through genetic engineering that are plant pests or 
that there is reason to believe are plant pests. Such genetically 
engineered organisms (GE) and products are considered ``regulated 
articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.
    On September 25, 2013,\1\ APHIS announced its determination of 
nonregulated status of corn (Zea mays) designated as event VCO-01981-5 
(hereinafter Genective VCO-01981-5 corn), which was genetically 
engineered for resistance to the herbicide glyphosate. On June 20, 
2013,\2\ APHIS announced its determination of nonregulated status of 
corn designated as event DP-004114-3 (hereinafter Pioneer 4114 corn), 
which was genetically engineered for resistance to the herbicide 
glufosinate-ammonium. APHIS has received a request for an extension of 
a determination of nonregulated status of Genective VCO-01981-5 corn 
and Pioneer 4114 corn to corn designated as event MZHG0JG (APHIS 
Petition Number 15-124-01p) from Syngenta Seeds Inc. (Syngenta) of 
Research Triangle Park, NC. MZHG0JG corn expresses resistance to both 
glyphosate and glufosinate-ammonium. In its request, Syngenta stated 
that this corn is similar to the antecedent organisms, Genective VCO-
01981-5 corn and Pioneer 4114 corn and, based on the similarity to 
these antecedent organisms, is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
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    \1\ https://www.aphis.usda.gov/brs/aphisdocs/11_34201p_det.pdf.
    \2\ https://www.aphis.usda.gov/brs/aphisdocs/11_24401p_det.pdf.
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    As described in the extension request, MZHG0JG corn was developed 
through agrobacterium-mediated transformation to stably incorporate the 
transgenes

[[Page 65688]]

mepsps-02 and pat-09 into the MZHG0JG corn genome. The gene mepsps-02 
encodes the enzyme modified 5-enol pyruvylshikimate-3-phosphate 
synthase (mEPSPS), a variant of the native EPSPS enzyme from corn, 
which contains two amino acid substitutions that were introduced 
specifically to confer resistance to herbicides containing glyphosate. 
The gene pat-09 encodes the enzyme phosphinothricin acetyltransferase 
(PAT) derived from the soil bacterium Streptomyces viridochromogenes. 
PAT acetylates glufosinate-ammonium, thus inactivating it and 
conferring resistance to glufosinate-ammonium in herbicide products. 
The antecedent organisms, Genective VCO-01981-5 corn and Pioneer 4114 
corn, were similarly genetically engineered to produce proteins which 
catalyze the same reactions as do the proteins produced in MZHG0JG 
corn. Based on the information in the request, we have concluded that 
MZHG0JG corn is similar to Genective VCO-01981-5 corn and Pioneer 4114 
corn. MZHG0JG corn is currently regulated under 7 CFR part 340.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS evaluates the plant pest risk of the article. 
In section 403 of the PPA, ``plant pest'' is defined as any living 
stage of any of the following that can directly or indirectly injure, 
cause damage to, or cause disease in any plant product: A protozoan, a 
nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or 
viroid, an infectious agent or other pathogen, or any article similar 
to or allied with any of the foregoing.
    APHIS completed plant pest risk assessments (PPRA) on the 
antecedent organisms in which we concluded that Genective VCO-01981-5 
corn and Pioneer 4114 corn are unlikely to present plant pest risks. 
APHIS also prepared a plant pest risk similarity assessment (PPRSA) to 
compare MZHG0JG to the antecedents. As described in the PPRSA, the 
proteins expressed in MZHG0JG corn are similar to those expressed in 
Genective VCO-01981-5 corn and Pioneer 4114 corn, and APHIS has 
concluded that the proteins expressed in Genective VCO-01981-5 corn and 
Pioneer 4114 corn are unlikely to affect the plant pest risk of 
Genective VCO-01981-5 corn and Pioneer 4114 corn. Furthermore, the 
Environmental Protection Agency reviewed the safety of the proteins 
expressed in MZHG0JG corn and concluded that adverse effects will not 
occur to nontarget organisms. Therefore, based on our PPRAs for 
Genective VCO-01981-5 corn and Pioneer 4114 corn and the similarity 
between Genective VCO-01981-5 corn, Pioneer 4114 corn, and MZHG0JG corn 
as described in the PPRSA, APHIS has concluded that the proteins 
expressed in MZHG0JG corn are unlikely to pose a plant pest risk and 
that MZHG0JG corn is unlikely to pose a different plant pest risk than 
Genective VCO-01981-5 corn and Pioneer 4114 corn.
    APHIS also prepared an environmental assessment (EA) for MZHG0JG 
corn based on our analysis of data submitted by Syngenta, a review of 
other scientific data, and field tests conducted under APHIS oversight. 
The EA was prepared to provide the APHIS decisionmaker with a review 
and analysis of any potential environmental impacts associated with the 
determination of nonregulated status for MZHG0JG corn. The EA was 
prepared in accordance with: (1) The National Environmental Policy Act 
of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.); (2) regulations of 
the Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508); (3) USDA regulations 
implementing NEPA (7 CFR part 1b); and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    In addition, APHIS has carefully examined the existing NEPA 
documentation completed for Genective VCO-01981-5 corn and Pioneer 4114 
corn and has concluded that Syngenta's request to extend a 
determination of nonregulated status to MZHG0JG corn encompasses the 
same scope of environmental analysis as Genective VCO-01981-5 corn and 
Pioneer 4114 corn. Therefore, based on the similarity of MZHG0JG corn 
to Genective VCO-01981-5 corn and Pioneer 4114 corn, APHIS has prepared 
a preliminary finding of no significant impact (FONSI) on MZHG0JG corn. 
APHIS is considering the following alternatives: (1) Take no action, 
i.e., APHIS would not change the regulatory status of MZHG0JG corn and 
it would continue to be a regulated article, or (2) make a 
determination of nonregulated status of MZHG0JG corn. APHIS' preferred 
alternative is to make a determination of nonregulated status of 
MZHG0JG corn.
    APHIS has analyzed information submitted by Syngenta, references 
provided in the extension request, peer-reviewed publications, and 
information in the EAs of the antecedent organisms. APHIS has also 
analyzed information in the PPRAs for the antecedent organisms, and 
other information. Based on APHIS' analysis of this information, the 
similarity of MZHG0JG corn to the antecedent organisms, our conclusion 
that the proteins expressed in MZHG0JG corn are unlikely to pose a 
plant pest risk, and our conclusion that MZHG0JG corn is unlikely to 
pose a different plant pest risk than Genective VCO-01981-5 corn and 
Pioneer 4114 corn, APHIS has determined that MZHG0JG corn is unlikely 
to pose a plant pest risk. We have therefore reached a preliminary 
decision to approve the request to extend the determination of 
nonregulated status of Genective VCO-01981-5 corn and Pioneer 4114 corn 
to MZHG0JG corn, whereby MZHG0JG corn would no longer be subject to our 
regulations governing the introduction of certain genetically 
engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of Genective VCO-01981-5 corn and Pioneer 4114 corn to MZHG0JG 
corn.
    APHIS will accept written comments on the preliminary FONSI 
regarding a determination of nonregulated status of MZHG0JG corn for a 
period of 30 days from the date this notice is published in the Federal 
Register. The preliminary FONSI, as well as the extension request, 
supporting documents, and our preliminary determination with appended 
PPRSA for MZHG0JG corn, are available for public review as indicated 
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of 
these documents may also be obtained by contacting the person listed 
under FOR FURTHER INFORMATION CONTACT.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments will be available for public review. After 
reviewing and evaluating the comments, if APHIS determines that no 
substantive information has been received that would warrant APHIS 
altering its preliminary regulatory determination or FONSI, our 
preliminary regulatory determination will become final and effective 
upon notification of the public through an announcement on our Web site 
at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml. APHIS will also furnish a response to 
the petitioner regarding

[[Page 65689]]

our final regulatory determination. No further Federal Register notice 
will be published announcing the final regulatory determination 
regarding MZHG0JG corn.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 22nd day of October.
Michael C. Gregoire,
Associate Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-27296 Filed 10-26-15; 8:45 am]
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